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Northwest Biotherapeutics: Company is Closing in on Unblinding of the Phase 3 Trial of DCVax-L in GBM That Could Lead to a Cascade of Important Follow-On Events (NWBO, Buy, $0.22)
Key Points In the third quarter 10-Q regulatory filing, it was disclosed that the draft form of the trial’s Statistical Analysis Plan (SAP) has been finalized for the phase 3 trial of DCVax-L in glioblastoma multiforme (GBM). This followed lengthy and extensive work on the part of independent statisticians and the distinguished Scientific Advisory Board. […]
Northwest Biotherapeutics: A More Thorough Discussion of the Potential Survival Tail of DCVax-L in Newly Diagnosed GBM than Originally Presented in My September 17, 2019 Report (NWBO, Buy, $0.25)
Reason for This Further Discussion A number of subscribers have pointed out to me that my discussion of the survival tail could have been more clearly explained. Consequently, I have rewritten two sections as shown below that will hopefully be clearer. I have also summarized my analysis as follows: In the CheckMate trials in second […]
Northwest Biotherapeutics: Management’s Decision to Determine Survival Tail for DCVax-L in Phase 3 Trial in Newly Diagnosed Glioblastoma Was Absolutely the Right Move (NWBO, Buy, $0.25)
Key Points: NWBO is approaching unblinding of the critical phase 3 trial of DCVax-L in newly diagnosed glioblastoma (GBM). Management let the trial run longer in order to determine if there is a survival tail. This should prove critical to potential regulatory approval and commercialization. A meaningful survival tail has been key to the huge […]
Northwest Biotherapeutics: Takeaways from Marnix Bosch’s Presentation at ASCO (NWBO, Buy, $0.27)
Overview Marnix Bosch, Chief Technical Officer of Northwest Biotherapeutics, discussed three broad topics at ASCO on Sunday June 2, 2019. Factors that will determine when we might see the all-important topline data from the phase 3 trial of DCVax-L in newly diagnosed glioblastoma multiforme (GBM). The hypothesized mode of action of DCVax Direct and plans […]
Northwest Biotherapeutics: Non-Dilutive Financing Provides Major Boost to Investment Outlook (NWBO, $0.25, Buy)
Key Points: Monetization of a UK manufacturing facility has brought in roughly $46 million of non-dilutive cash. I estimate that payment of debt obligations over the next two years will require about $10 million leaving $36 million to fund operations. At the recent quarterly burn rate of $5 million, NWBO can fund operations through mid-2020. […]
Northwest Biotherapeutics: Blinded Data from DCVax®-L Phase 3 Trial is Extremely Encouraging, But We Still Need to See Unblinded Data (NWBO, Buy, $0.29)
Overview This report starts with a summary of the key aspects of my investment thinking on Northwest,updated for the just reported refresh on blinded data from the DCVax®-L phase 3 trial in newly diagnosed glioblastoma multiforme (GBM). This is followed by further discussion on why I believe the blinded data strongly hints at a medically […]
Northwest Biotherapeutics: There could be Overwhelming Patient Demand for DCVax-L due to the Right to Try law (NWBO, $0.24, Buy)
Investment Thesis in Brief I believe that it is now a matter of when rather than if DCVax-L is approved and becomes an integral part of standard of care (SOC) for newly diagnosed glioblastoma multiforme. I estimate that the worldwide addressable market is $5.5 billion and I would expect DCVax-L to penetrate a very significant […]
Northwest Biotherapeutics; Five Spectacular Patient Outcomes for Patients Treated with DCVax-L as Reported at ASCO (NWBO, $0.28, Buy)
Purpose of Report: At ASCO, Northwest sponsored a meeting attended by investigators in the phase 3 trial and other oncologists not involved in the trial. During the meeting, five patients gave testimonials on the spectacular outcomes that they had achieved due to treatment with DCVax-L. Four of these patients were treated in compassionate use programs […]
Northwest Biotherapeutics: Right to Try Law Potentially Could Lead to Meaningful Revenues Prior to Formal Approval of DCVax-L (NWBO, Buy, $0.30)
Investment Perspective Last week, a manuscript was published in a peer reviewed journal that dealt with blinded results of the phase 3 trial of DCVax-L that is investigating its use in newly diagnosed glioblastoma multiforme, the most deadly form of brain cancer. . The article was co-authored by 69 leading oncologists who participated in the […]
Northwest Biotherapeutics: Blinded Data from Phase 3 Trial Strongly Suggests that DCVax-L is a Major Advance in the Treatment of Newly Diagnosed Glioblastoma Multiforme; It Looks Like NWBO Has Hit a Therapeutic and Commercial Home Run (NWBO, Buy, $0.25)
Investment Hypothesis on Dendritic Cell Cancer Vaccines I have no academic background in immunology so that you should take that into account as you read this hypothesis. You must recognize that mine is the view of a layman. That said, here is my hypothesis on the potentially breakthrough role for DCVax-L and dendritic cell cancer […]